Developing the Covid-19 vaccine

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shpalman
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Re: Developing the Covid-19 vaccine

Post by shpalman » Tue Apr 27, 2021 7:40 pm

Herainestold wrote:
Tue Apr 27, 2021 7:32 pm
bolo wrote:
Tue Apr 27, 2021 6:00 pm
I presume that if all the other vaccine manufacturers came to the EMA with safety and efficacy data and license applications, it would happily evaluate them. The fact that it hasn't already is presumably because the manufacturers haven't asked it to, or haven't provided adequate data.

At least, that's how most regulatory agencies work.
I think you're right. My point is that the EMA is the most esteemed regulator and if all vaccines were evaluated by them, it would be easier to compare them and there would be no stigma applied to vaccines that didnt have the check mark of any particular regulator.
I think if the vaccine is going to be administered in an EU country it needs approval first from the EMA, and then each national regulator, although the national regulators can bypass the EMA if they really really want to.
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Re: Developing the Covid-19 vaccine

Post by shpalman » Wed Apr 28, 2021 5:23 pm

Seems like Pfizer want to sell a third dose in September or so, just about when we're finished with giving everyone their second doses.
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Re: Developing the Covid-19 vaccine

Post by jimbob » Wed Apr 28, 2021 8:36 pm

Does anyone with more understanding than me know if this thread is an oversimplification or whether it's accurate?

https://twitter.com/angie_rasmussen/sta ... 05893?s=20
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The Sputnik V vaccine Ad5 vector is evidently replication competent. The makers apparently neglected to delete E1, so getting this vaccine means being infected with live adenovirus 5.

Hence Brazil’s regulator correctly rejected it.
Have you considered stupidity as an explanation

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Re: Developing the Covid-19 vaccine

Post by bob sterman » Wed Apr 28, 2021 9:06 pm

jimbob wrote:
Wed Apr 28, 2021 8:36 pm
Does anyone with more understanding than me know if this thread is an oversimplification or whether it's accurate?
Well the potential problem - the viral vectors in Sputnik V being replication competent - is getting media coverage...

https://www.ctvnews.ca/health/coronavir ... -1.5403539

https://www.reuters.com/business/health ... 021-04-27/

But the official Sputnik V vaccine Twitter account is claiming it's "fake news"...

https://twitter.com/sputnikvaccine/stat ... 7093696512

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Re: Developing the Covid-19 vaccine

Post by jdc » Wed Apr 28, 2021 9:21 pm

jimbob wrote:
Wed Apr 28, 2021 8:36 pm
Does anyone with more understanding than me know if this thread is an oversimplification or whether it's accurate?

https://twitter.com/angie_rasmussen/sta ... 05893?s=20
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The Sputnik V vaccine Ad5 vector is evidently replication competent. The makers apparently neglected to delete E1, so getting this vaccine means being infected with live adenovirus 5.

Hence Brazil’s regulator correctly rejected it.
There's some discussion below that tweet about whether it's a failure to delete E1 f.ckup or a recombination f.ckup but the important bits "replication competent" and "infected with live adenovirus" don't seem to be disputed there. And for confirmation of those points: the FT reports that
Anvisa said the presence of adenoviruses with the ability to replicate — a naturally occurring process that has to be neutralised for immunisations — had been detected, which can “lead to infections in humans and could cause damage and death, especially in people with low immunity and respiratory problems, among other health problems”.

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Re: Developing the Covid-19 vaccine

Post by Herainestold » Thu Apr 29, 2021 12:42 am

The always excellent Derek Lowe:
A tip for the vaccine’s manufacturers: don’t immediately start accusing your critics of bad faith, especially when they are the regulatory authorities. Step up and act like responsible drug developers: address the issues directly, with transparency, and work to find a solution. Throwing fits on Twitter is not the answer.
I was a big fan of Sputnik, until this. Kudos to the Brazilians for catching it.

https://blogs.sciencemag.org/pipeline/a ... ya-vaccine

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Re: Developing the Covid-19 vaccine

Post by Woodchopper » Thu Apr 29, 2021 4:30 am

Herainestold wrote:
Thu Apr 29, 2021 12:42 am
The always excellent Derek Lowe:
A tip for the vaccine’s manufacturers: don’t immediately start accusing your critics of bad faith, especially when they are the regulatory authorities. Step up and act like responsible drug developers: address the issues directly, with transparency, and work to find a solution. Throwing fits on Twitter is not the answer.
I was a big fan of Sputnik, until this. Kudos to the Brazilians for catching it.

https://blogs.sciencemag.org/pipeline/a ... ya-vaccine
Yes, good article on the problems with the Sputnik vaccine.

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Re: Developing the Covid-19 vaccine

Post by jimbob » Thu Apr 29, 2021 7:47 am

And their responses - as discussed in Lowe's followup blogpost: https://blogs.sciencemag.org/pipeline/a ... e-behavior

show the what happens when an autocratic regime uses vaccine development and supply as an instrument of Russian soft power.
Have you considered stupidity as an explanation

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Re: Developing the Covid-19 vaccine

Post by shpalman » Fri Apr 30, 2021 7:09 am

shpalman wrote:
Wed Apr 28, 2021 5:23 pm
Seems like Pfizer want to sell a third dose in September or so, just about when we're finished with giving everyone their second doses.
and then a dose every year

(also, as if we'd have finished all the over-16's by June in Europe... it's more likely to be early October at best)
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Re: Developing the Covid-19 vaccine

Post by shpalman » Fri Apr 30, 2021 7:12 am

jimbob wrote:
Thu Apr 29, 2021 7:47 am
And their responses - as discussed in Lowe's followup blogpost: https://blogs.sciencemag.org/pipeline/a ... e-behavior

show the what happens when an autocratic regime uses vaccine development and supply as an instrument of Russian soft power.
Yeah it's a bad look when criticism is taken as being political for concerns which turn out to be valid.
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Re: Developing the Covid-19 vaccine

Post by jimbob » Fri Apr 30, 2021 8:48 am

shpalman wrote:
Fri Apr 30, 2021 7:12 am
jimbob wrote:
Thu Apr 29, 2021 7:47 am
And their responses - as discussed in Lowe's followup blogpost: https://blogs.sciencemag.org/pipeline/a ... e-behavior

show the what happens when an autocratic regime uses vaccine development and supply as an instrument of Russian soft power.
Yeah it's a bad look when criticism is taken as being political for concerns which turn out to be valid.
Indeed, "at least it's not as bad as an arm of Putin's government" is not really a ringing endorsement.
Have you considered stupidity as an explanation

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Re: Developing the Covid-19 vaccine

Post by tom p » Sat May 01, 2021 9:17 am

bolo wrote:
Tue Apr 27, 2021 6:00 pm
I presume that if all the other vaccine manufacturers came to the EMA with safety and efficacy data and license applications, it would happily evaluate them. The fact that it hasn't already is presumably because the manufacturers haven't asked it to, or haven't provided adequate data.

At least, that's how most regulatory agencies work.
You presume correctly.
No application means nothing to review.

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Re: Developing the Covid-19 vaccine

Post by tom p » Sat May 01, 2021 9:24 am

shpalman wrote:
Tue Apr 27, 2021 7:40 pm
Herainestold wrote:
Tue Apr 27, 2021 7:32 pm
bolo wrote:
Tue Apr 27, 2021 6:00 pm
I presume that if all the other vaccine manufacturers came to the EMA with safety and efficacy data and license applications, it would happily evaluate them. The fact that it hasn't already is presumably because the manufacturers haven't asked it to, or haven't provided adequate data.

At least, that's how most regulatory agencies work.
I think you're right. My point is that the EMA is the most esteemed regulator and if all vaccines were evaluated by them, it would be easier to compare them and there would be no stigma applied to vaccines that didnt have the check mark of any particular regulator.
I think if the vaccine is going to be administered in an EU country it needs approval first from the EMA, and then each national regulator, although the national regulators can bypass the EMA if they really really want to.
The emboldened part is not quite right. Medicines are either approved nationally (e.g. yet another paracetamol tablet) or centrally via the EMA (new biologicals/vaccines and various other medicines). Once it's approved centrally, it's approved everywhere immediately.
The stamp of approval is given by the EC, but it's a metaphorical rubber stamp, based entirely on the opinion of the CHMP (committee on human medicinal products), which is formed of representatives from every EU member state (1 + an alternate from every MS).

EEA MS can approve medicines for emergency distribution (which is not the same as an authorisation). It's what the UK did with the AZ vaccine in December 2020 & it's what Hungary has done with SinoVac & Sputnik. This is because national governments are supreme when it comes to the health of their own population, despite what brexit fantasists would have us believe.

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Re: Developing the Covid-19 vaccine

Post by shpalman » Sat May 01, 2021 1:41 pm

Good to know that posting the wrong answer is still the most effective way of getting someone to post the right answer.

(Here's what the EMA has recently said in a pdf on the AIFA website. I note it says "to support national authorities making decisions" i.e. not "regulators".)

In Italy's case then it seems like it's the national health service,* and not the AIFA, which has decided to avoid giving Vaxzevia to younger subjects (despite the EMA conditionally authorizing it for 18+ and the AIFA mirroring this) and still doesn't seem to have decided on whether to use it for the second doses of those who already got first doses of it back when it was recommended only for younger ages.

But I definitely had the impression that the AIFA's approval meant something a bit more than "yeah, what the EMA said". Maybe that's just what the Italians want to tell themselves.

I think AIFA was anyway still responsible for deciding what to do when there were those adverse effects at the beginning of March.

* - ok this is complicated because there's the "superior health institute" (ISS) which does the covid monitoring and modelling, and "civil protection agency" (both the health service and the military are part of it and it's now the army which is in charge of the vaccine rollout under Francesco Paolo Figliuolo) in addition to the health ministry itself.
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Re: Developing the Covid-19 vaccine

Post by Herainestold » Sun May 02, 2021 5:08 pm

Chile is still keen on the sputnik vaccine despite Brazil rejecting it. The Chileans are implying it was merely a documentation issue.
The ISP's Garcia said discussions with RDIF had begun a month ago and were "100% positive" so far.

He said he was confident RDIF could supply the extra documentation the ISP had asked for before it began considering Sputnik V for approval for emergency rollout.

"I doubt that there is a problem but we as a regulator need that information so we as a health authority can reassure our population," he said.

He said Brazil's rejection of Sputnik V over missing documentation was "valid" but that the ISP would avoid a similar issue by insisting on all the necessary documentation about Sputnik V before formally considering it for use in Chile.

"This avoids generating mistrust about vaccines which won't get us anywhere," he said.
https://news.yahoo.com/exclusive-chilea ... 37114.html

Dr. Angela Rasmussen of Georgetown (see twitter thread in jimbob's post above):
They told me to stop spreading fake news. As I mentioned before, the Gamaleya Institute has a great reputation and their scientists are excellent, so I don’t think that this was intentional. But that said, I don’t consider it fake news when a country’s regulatory agency presents data showing that, in fact, there is replication-competent virus in the lots that they evaluated. That’s not fake news. That is an observation and that directly contradicts what their statement says. So I think that it would be a good idea for Sputnik to be cooperative with these regulatory agencies, because I don’t think that you can just point to a statement and say, oh, this is fake news.
So did the Brazilians find replication competent adenovirus, or not? Is it just a documentation problem or a manufacturing problem or is it just geo-politics?
Buried deep in the dry, 72-page annual report of the U.S. Department of Health and Human Services lay a startling admission: U.S. health officials under President Donald Trump worked to convince Brazil to reject Russia’s Sputnik V coronavirus vaccine…

https://blogs.sciencemag.org/pipeline/a ... ent-343660

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Re: Developing the Covid-19 vaccine

Post by jdc » Sun May 02, 2021 6:38 pm

Well the Brazilian regulator said their reason for rejection was that they'd found adenoviruses with the ability to replicate and I think they'd know better than Chile what their reasons were for rejecting the vaccine.

It seems to me that with regards the detection of replication-competent adenovirus in Sputnik, in the absence of verification by a trusted third party, all we can do is either withhold judgement or choose between Anvisa and RDIF.

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Re: Developing the Covid-19 vaccine

Post by Woodchopper » Sun May 02, 2021 7:29 pm

The Monday announcement left many scientists and media outlets believing Anvisa had directly tested Sputnik V for replicating adenoviruses, which would be unusual for a regulatory agency. But Anvisa has since clarified—it had not and was relying on information provided by the Gamaleya National Center of Epidemiology and Microbiology, the Moscow-based developer of the vaccine.

“The data we evaluated shows the presence of replicating virus,” Gustavo Mendes, general manager of medicines and biological products at Anvisa, said at the press conference. Anvisa would not accept the vaccine, he said, without further studies to indicate it is safe.

Gamaleya said in a statement on its website that Anvisa’s allegations “have no scientific grounds and cannot be treated seriously.” The research institute added that “no replication-competent adenoviruses (RCA) were ever found in any of the Sputnik V vaccine batches” and said a four-stage purification process prevents contamination.

[...]

Vaccinemakers and others have developed tests to check for replicating adenoviruses in their products. Anvisa said that although the standard worldwide has been zero tolerance for the presence of replicating adenovirus in the vaccine, Gamaleya established an acceptable limit of 5000 replication-capable virus particles per vaccine dose. The Russian quality control documents displayed by Anvisa during the press conference state the batches tested had “less than 100” replication-capable particles per dose.

During yesterday’s press conference, Mendes also showed video of parts of an online meeting in March between officials from Anvisa and the vaccine’s developer. In one of the clips, Anvisa officials ask Gamaleya representatives why they had not changed their production methods once they “had detected the RCA occurrence in your production” The Gamaleya representatives responded that they were aware of the risk, but that changing the process “would take too much time.”

Mendes noted that Anvisa has analyzed the quality control documentation on other adenovirus-based COVID-19 vaccines, such as those made by AstraZeneca and Johnson & Johnson, and found no evidence of replication-competent viruses in those companies’ final products.

Immunologist Jorge Kalil, a vaccine expert at the Federal University of São Paulo, São Paulo, and member of the Data and Safety Monitoring Board at the U.S. National Institutes of Health, disagrees with Anvisa’s interpretation. He believes Russian quality-control documents are actually referring to the sensitivity of the testing. “When the Russians say ‘less than 100 parts per dose’ they are not saying if there are replicant viruses [in the dose] or not,” he contends. “What they are saying is that if there are viruses, they are [there] in less than 100 parts per dose.”

Mendes told Science this is not the case and that if it were, Gamaleya would have reported “no detection.” One way or the other, Anvisa won’t tolerate replicating virus in the vaccine and needs more assurance there is none. “The limit for us is zero,” agency President, Antonio Barras said during the press conference.

[...]

Anvisa also reported a long list of other issues with the vaccine that it wants the Russians to address. Those include the lack of detailed information on the 63 cases of adverse events and four deaths reported during the clinical trial. (The Lancet paper on Sputnik V’s efficacy trial reported no serious adverse events or deaths were deemed to be related to vaccination.)

The Brazilian agency also complains that during an inspection trip to Russia in April its technicians were only allowed to visit three of seven manufacturing sites—and were not allowed to visit Gamaleya’s quality-control center. As a result, “It is not possible to verify the existence of standards within the … facilities,” according to an Anvisa report published Monday with the veto announcement.

“So, the word that sums up the visit to Russia is frustration,” Anvisa Director Alex Machado Campos said during the Monday discussion on the import vote, according to a video of the event.

Mendes yesterday said these issues alone, even without the possible presence of the replicating adenovirus, “would be enough to reject” the import request. It was the totality of the deficiencies that led to Anvisa’s decision, he says.
https://www.sciencemag.org/news/2021/04 ... threat-and

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Re: Developing the Covid-19 vaccine

Post by Woodchopper » Sun May 02, 2021 7:31 pm

Link to the press conference. Some slides are in English: https://youtu.be/fCtCvc5dib0

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Re: Developing the Covid-19 vaccine

Post by shpalman » Sun May 02, 2021 9:05 pm

Vaccinemakers and others have developed tests to check for replicating adenoviruses in their products. Anvisa said that although the standard worldwide has been zero tolerance for the presence of replicating adenovirus in the vaccine, Gamaleya established an acceptable limit of 5000 replication-capable virus particles per vaccine dose. The Russian quality control documents displayed by Anvisa during the press conference state the batches tested had “less than 100” replication-capable particles per dose.

During yesterday’s press conference, Mendes also showed video of parts of an online meeting in March between officials from Anvisa and the vaccine’s developer. In one of the clips, Anvisa officials ask Gamaleya representatives why they had not changed their production methods once they “had detected the RCA occurrence in your production” The Gamaleya representatives responded that they were aware of the risk, but that changing the process “would take too much time.”

Mendes noted that Anvisa has analyzed the quality control documentation on other adenovirus-based COVID-19 vaccines, such as those made by AstraZeneca and Johnson & Johnson, and found no evidence of replication-competent viruses in those companies’ final products.

Immunologist Jorge Kalil, a vaccine expert at the Federal University of São Paulo, São Paulo, and member of the Data and Safety Monitoring Board at the U.S. National Institutes of Health, disagrees with Anvisa’s interpretation. He believes Russian quality-control documents are actually referring to the sensitivity of the testing. “When the Russians say ‘less than 100 parts per dose’ they are not saying if there are replicant viruses [in the dose] or not,” he contends. “What they are saying is that if there are viruses, they are [there] in less than 100 parts per dose.”

Mendes told Science this is not the case and that if it were, Gamaleya would have reported “no detection.” One way or the other, Anvisa won’t tolerate replicating virus in the vaccine and needs more assurance there is none. “The limit for us is zero,” agency President, Antonio Barras said during the press conference.
Is it feasible to insist on zero if the lower detection limit is 100? Is there a process which has a detection limit of 1, out of about 50000000000 viral particles per dose?

It's like when bleach "kills 99.9% of known germs", that's just because they can't detect fewer than that.
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Re: Developing the Covid-19 vaccine

Post by Bird on a Fire » Mon May 03, 2021 12:53 pm

Science in Brazil has been enormously politicised since Bolsonaro took charge. I can't speak for Avisa specifically, but let's just say I wouldn't be at all surprised if this were a political response rather than a genuine scientific concern.
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Re: Developing the Covid-19 vaccine

Post by tom p » Mon May 03, 2021 2:20 pm

shpalman wrote:
Sat May 01, 2021 1:41 pm
Good to know that posting the wrong answer is still the most effective way of getting someone to post the right answer.

(Here's what the EMA has recently said in a pdf on the AIFA website. I note it says "to support national authorities making decisions" i.e. not "regulators".)

In Italy's case then it seems like it's the national health service,* and not the AIFA, which has decided to avoid giving Vaxzevia to younger subjects (despite the EMA conditionally authorizing it for 18+ and the AIFA mirroring this) and still doesn't seem to have decided on whether to use it for the second doses of those who already got first doses of it back when it was recommended only for younger ages.

But I definitely had the impression that the AIFA's approval meant something a bit more than "yeah, what the EMA said". Maybe that's just what the Italians want to tell themselves.

I think AIFA was anyway still responsible for deciding what to do when there were those adverse effects at the beginning of March.

* - ok this is complicated because there's the "superior health institute" (ISS) which does the covid monitoring and modelling, and "civil protection agency" (both the health service and the military are part of it and it's now the army which is in charge of the vaccine rollout under Francesco Paolo Figliuolo) in addition to the health ministry itself.
For these vaccines, AIFA (as a national Competent Authority) doesn't even have any approval, not even a 'what-he-said', pretending-to-be-important sort of approval. The Italian government and other bodies may look to them for detailed advice as to whether or not to actually use the vaccine within Italy and on whom; but, following the CHMP decision & EC approval, it is authorised for marketing within Italy. The same is true throughout the EEA. The countries which 'suspended' the vaccine were only suspending the vaccination programme - the act of sticking it in their citizens' arms, rather than the right for AZ to sell it within those countries or for those citizens to obtain the product (via doctors), should some be available.

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Re: Developing the Covid-19 vaccine

Post by shpalman » Mon May 03, 2021 6:08 pm

Figliuolo has indeed been saying that he's considering using AstraZeneca for under-60s again, but I'm not sure what extra data he's waiting for, since we won't know what the adverse effect rate in Italians in the 50-59 age range would be unless we give it to a load of them. But as you point out, it's his decision as the person in charge of the rollout.

We do of course still have a worse case and death rate than the UK, which has only decided it's not worth it to give it to under-30's.
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Re: Developing the Covid-19 vaccine

Post by Herainestold » Tue May 04, 2021 7:28 pm

EMA to start rolling review of Sinovac vaccine.
The European Union’s drug regulator announced Tuesday that it has started a rolling review of China’s Sinovac coronavirus vaccine to assess its effectiveness and safety, a first step toward possible approval for use in the 27-nation bloc.
Looks like a good move as Europe needs more diversity in its vaccine supply.
The agency said its experts will “evaluate data as they become available to decide if the benefits outweigh the risks" of the vaccine. The rolling review will continue until “enough evidence is available for a formal marketing authorization application,” the EMA said, adding that it could not predict timelines.

The announcement from the Amsterdam-based agency came a day after a top World Health Organization official said the WHO is set to decide this week whether to approve two Chinese COVID-19 vaccines for emergency use.
https://www.msn.com/en-xl/europe/top-st ... r-BB1glkFA

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Re: Developing the Covid-19 vaccine

Post by shpalman » Wed May 05, 2021 7:27 pm

https://www.sciencemag.org/news/2021/05 ... own-latest

Science magazine on the risk:benefit from the adenovirus based vaccines.
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Re: Developing the Covid-19 vaccine

Post by shpalman » Sat May 08, 2021 7:06 am

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